Work Output. All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) (which shall be commercially reasonable) unless otherwise specified in the Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement Unless otherwise required by law, KBI Biopharma shall maintain records related to each Proposal, including, but not limited to the Services, accounting records, time sheets, written policies and procedures, test results, reports, correspondence, memoranda and any other documentation relating to the performance of its obligations under to this Agreement (“Records”). KBI Biopharma shall, during normal working hours, and with reasonable advance notice, permit Client or its authorized agents to inspect, audit and/or reproduce Records (i) to the extent necessary to adequately evaluate invoices submitted to Client by KBI Biopharma hereunder, (ii) as required by governmental authorities or (iii) as desired by Client for any other valid business purpose related to this Agreement. Vendor shall make appropriate personnel or other representatives available to Client and its agents to discuss Records and to resolve any questions or issues relating thereto. Such audits shall not be conducted more frequently than once per year. KBI Biopharma shall maintain all information and data generated by it in the course of providing the Services, including all Work Output, computerized records and files, in a secure area reasonably protected from fire, theft and destruction. To the extent not delivered prior to the expiration or termination of this Agreement, at the expiration or termination of this Agreement and upon the written request of Client, all Records, data, information and tangible property obtained or generated by KBI Biopharma in the course of providing the Services or arising out of the use of Client’s Confidential Information (collectively, “Results”) shall, at Client’s option, be (a) delivered to Client at any address as Client may specify in such request, or (b) retained by KBI Biopharma for a period of five (5) years from the completion of the Services or such longer period required by applicable laws and regulations. Client shall reimburse KBI Biopharma for the reasonable, documented cost of deliveries to Client under this Section 4. In no event shall KBI Biopharma dispose of...
Work Output. All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement. All Work Output and any required Product samples will be at Client’s option, (a) delivered to Client at any address as Client may specify in such request, or (b) archived by KBI Biopharma for a period of five (5) years following completion of the Services unless otherwise provided in the Proposal or required by applicable U.S. laws or regulations. At such time after completion of the Services, Work Output and Product samples will be sent to Client and a reasonable return fee will be charged. If Client chooses to have KBI Biopharma dispose of Work Output and Product samples, a reasonable disposal fee will be charged. Not more than once annually, KBI Biopharma shall, during normal working hours, and with reasonable advance notice, permit Client or its authorized agents to inspect, audit and/or reproduce Records (i) to the extent necessary to adequately evaluate invoices submitted to Client by KBI Biopharma hereunder, (ii) as required by governmental authorities or (iii) as desired by Client for any other valid business purpose related to this Agreement.
Work Output a) All reports specified in the SoW and other cGMP documentation (“Work Output”) will be prepared using Fujifilm’s standard format(s) unless otherwise specified in the SoW.
b) Alder will be supplied with copies of Work Output generated as a result of the Program as set forth in the applicable SoW or Quality Agreement. All Work Output and agreed Product samples will be archived by Fujifilm for a period of [***] following completion of the Program unless otherwise defined by the Program or required by applicable U.S. and European laws or regulations. [***] after completion of the Program, Work Output and Product samples will be sent to Alder and a [***]. Alder may elect to have the materials retained in the Fujifilm archives for an additional period of time [***]. If Alder chooses to have Fujifilm dispose of Work Output and Product samples, [***]. Notwithstanding the foregoing, Fujifilm will continue to retain such written materials and Product samples as required [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. by regulations and as may be required by law, pertaining to such activities as well as for archival purposes. All Work Output shall be owned by Alder and shall be its Confidential Information.
Work Output a) All information, data, documentation and reports produced by Fujifilm in the conduct of the Program and/or all other cGMP documentation (“Work Output”) will be prepared by Fujifilm using Fujifilm’s standard format(s).
b) Sponsor will be supplied with copies of Work Output as part of Batch Packet and Campaign summary reports. Fujifilm shall not be obliged to supply all data generated but instead will supply relevant data to Sponsor and Sponsor will have access to all data generated in relation to the Program for on-site review either (i) during any audits or (ii) upon Sponsor’s written request. All Work Output and Product samples will be archived by Fujifilm as required by the Quality Agreement or for a period of five (5) years, whichever is longer. Sponsor may elect to have the Work Output retained in the Fujifilm archives for an additional period of time at additional cost to Sponsor. If Sponsor chooses to have Fujifilm dispose of Work Output and Product samples, a reasonable disposal fee will be charged. Notwithstanding the foregoing, Fujifilm will continue to retain such Work Output and Product samples as required by Applicable Law pertaining to such activities as well as for archival purposes. In the absence of such notice, at the end of the applicable period, Fujifilm shall notify Sponsor of the expiration of such period and, upon notice from Sponsor, Fujifilm shall send the Work Output to Sponsor at Sponsor’s cost and expense.
Work Output. All reports specified in each Proposal and other applicable Batch Documentation (collectively, the “Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the applicable Proposal or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in each Proposal or Quality Agreement. All Work Output and any required Client Product samples will be archived by KBI Biopharma in electronic and, as required, paper form for a period of [***] following completion of the Services unless otherwise provided in the corresponding Proposal or required by Applicable Laws. At such time after completion of the Services, Work Output and Client Product samples will be sent to Client and a reasonable return fee will be charged to Client. If Client chooses to have KBI Biopharma dispose of Work Output and Client Product samples, a reasonable disposal fee will be charged.
Work Output. 4.1 All reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the Proposal, the Quality Agreement or this Agreement. Client will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality Agreement. Furthermore, for all work segments, Client shall have access to all raw data for on-site review during a facility visit (pursuant to Section 5 of this Agreement) and have access to and be provided 3
g. HPLC or calorimetric traces or assay work sheets), including through an electronic portal. All Work Output and any required Product samples will be archived by KBI Biopharma for a period of five (5) years following completion of the Services unless otherwise provided in the Proposal or required by applicable U.S. laws or regulations, at which time KBI Biopharma will notify Client of its options. At such time after completion of the Services, Work Output and Product samples will be sent to Client and a reasonable return fee will be charged. If Client chooses to have KBI Biopharma dispose of Work Output and Product samples, a reasonable disposal fee will be charged. Work Output shall include KBI Biopharma’s assistance in the transfer of all necessary, intellectual property, methods, processes, documentation and other information necessary to allow Client to utilize the work product arising from the Services, including the licenses granted hereunder.
Work Output. 6.1 All Work Output documents, reports or technical summaries and other cGMP documentation will be prepared using Diosynth’s standard format(s) unless otherwise specified in the Scope.
6.2 Diosynth agrees to grant and hereby grants to Neose an exclusive, worldwide, perpetual, non-revocable, fully-paid, royalty-free license to use the reports with the right to sublicense for uses reasonably related to Neose’s business.
6.3 Neose will be supplied with copies of all Work Output documents, reports or technical summaries, all other documentation generated as a result of the Program as set forth in the Scope or Quality Agreement and all other items generated by Diosynth as a result of the Program and reasonably requested by Neose. Unless instructed by Neose to destroy or return all Work Output, all Work Output will be archived by Diosynth for a period of five years following completion of the Program. Five years after completion of the Program, Work Output will be destroyed at Neose’s cost, or, at Neose’s request and expense, sent to Neose. Neose may elect to have the Work Output retained in the Diosynth archives for an additional period of time not to exceed an additional five years at a cost to Neose. Notwithstanding the foregoing, if required by Law, Diosynth will retain such Work Output, without charge to Neose, for such a period as is required by the applicable Law (which period may be more than 10 years). In addition, Diosynth may retain one copy of documentation for archival purposes.
Work Output. Boardroom’s work processes used, prepared or assembled by Boardroom during the Engagement, including Boardroom’s proprietary methodology, know-how and computer models (“Work Processes”) shall be the exclusive property of Boardroom. The Company shall not be entitled to the Work Processes. Boardroom shall retain copies of the Work Processes pursuant to its document retention policy as in effect from time to time. Upon the conclusion of the Engagement, Boardroom shall deliver to the Company any data, reports, or runs assembled or prepared by Boardroom for the Engagement specifically and for the benefit of the Company. The data, reports and runs shall be the property of the Company.
Work Output a) All Information, data, documentation and reports produced by Diosynth in the conduct of the Program and/or all other cGMP documentation (“Work Output”) will be prepared by Diosynth using Diosynth’s standard format(s) unless otherwise specified in the Scope.
b) Sponsor will be supplied with copies of Work Output generated as a result of the Program as set forth in the Scope or Quality Agreement. Notwithstanding the foregoing, Diosynth shall not be obliged to supply all data generated but instead will supply relevant data to Sponsor and Sponsor will have access to all data generated in relation to the Program for on-site review either (i) during any audits or (ii) upon Sponsor’s written request. All Work Output and Product samples will be archived by Diosynth for a period of five (5) years following completion of the Program unless otherwise defined by the Program or required by applicable U.S. laws or regulations. Five (5) years after completion of the Program, Work Output and Product samples will be disposed by Diosynth or sent by Diosynth to Sponsor and a return fee will be charged, as specified in writing by Sponsor. Sponsor may elect to have the Work Output retained in the Diosynth archives for an additional period of time at additional cost to Sponsor. If Sponsor chooses to have Diosynth dispose of Work Output and Product samples, a disposal fee will be charged. Notwithstanding the foregoing, Diosynth will continue to retain such Work Output and Product samples as required by regulations and as may be required by law, pertaining to such activities as well as for archival purposes. In the absence of notice at the end of the applicable period, Diosynth shall send the Work Product to Sponsor at Sponsor’s cost and expense.
Work Output a) All reports specified in the Scope and other cGMP documentation, including the Batch Record, Certificate of Analysis, and the Batch Packet (“Work Output”) will be prepared using Fujifilm’s standard format(s) unless otherwise specified in the Scope.
b) Sponsor will be supplied with copies of Work Output generated as a result of the Program as set forth in the Scope or Quality Agreement. All Work Output and Product samples will be archived by Fujifilm for a period of [* * *] years following completion of the Program unless otherwise defined by the Program or required by applicable U.S. laws or regulations. [* * *] after completion of the Program, Work Output and Product samples will be sent to Sponsor and a return fee will be charged. Sponsor may elect to have the materials retained in the Fujifilm archives for an additional period of time at additional cost to Sponsor. If Sponsor chooses to have Fujifilm dispose of Work Output and Product samples, a disposal fee will be charged. Notwithstanding the foregoing, Fujifilm will continue to retain such written materials and Product samples as required by regulations and as may be required by law, pertaining to such activities as well as for archival purposes.
